University Of Chicago Hospitals FDA Record
- Latest inspection VAI · Jul 17, 2025
- No warning letters matched by name
University Of Chicago Hospitals has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "University Of Chicago Hospitals" is on file.
- Latest inspection
- Jul 17, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 6 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
University Of Chicago Hospitals: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 17, 2025 | Chicago, IL | Biologics | Voluntary Action Indicated (VAI) | 3003966339 |
| Sep 7, 2022 | Chicago, IL | Biologics | No Action Indicated (NAI) | 3003966339 |
| Jun 20, 2017 | Chicago, IL | Biologics | No Action Indicated (NAI) | 3003966339 |
| Apr 30, 2015 | Chicago, IL | Biologics | No Action Indicated (NAI) | 3003966339 |
| May 16, 2012 | Chicago, IL | Biologics | No Action Indicated (NAI) | 3003966339 |
| Nov 18, 2009 | Chicago, IL | Biologics | No Action Indicated (NAI) | 3003966339 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003966339 | Chicago, IL | 6 | Jul 17, 2025 |
University Of Chicago Hospitals and the FDA: common questions
Has University Of Chicago Hospitals received an FDA warning letter?
No FDA warning letter addressed to the name "University Of Chicago Hospitals" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has University Of Chicago Hospitals received an FDA Form 483?
FDA has not published a Form 483 for "University Of Chicago Hospitals" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect University Of Chicago Hospitals?
The most recent FDA inspection on file ended Jul 17, 2025 at Chicago, IL and was classified VAI. FDA has 6 inspections of University Of Chicago Hospitals on file.
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